Systems and methods for tissue suspension and compression

ABSTRACT

Suture passer systems for tissue suspension and tissue compression are described. The system can include a shaft and a needle, wherein the needle is freely rotatable with respect to the shaft. The suture may include an overmolded segment. Methods of placing one or more implants, sutures, fastener, bone anchors and other devices are also described. The methods include moving tissue, including the superior pharyngeal constrictor muscle, palatopharyngeal arch, and palatoglossal arch. The methods include hyoid bone suspension.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57. Thisapplication is a continuation application of U.S. application Ser. No.16/128,816 filed Sep. 12, 2018, which is a continuation application ofU.S. application Ser. No. 14/639,774 filed Mar. 5, 2015, which claimsthe priority benefit under 35 U.S.C. § 119(e) as a nonprovisionalapplication of U.S. Provisional Application No. 61/948,473, filed onMar. 5, 2014, which are hereby incorporated by reference in its entiretyAlso incorporated by reference in their entireties is U.S. Pat. No.8,460,322 issued on Jun. 11, 2013, and U.S. Pat. Pub. No. 2014/0074518A1 published on Mar. 13, 2014.

BACKGROUND Field

In some aspects, the invention relates generally to suture passersystems and methods for tissue suspension and tissue compression.Disclosed herein are systems and methods for tissue suspension using oneor more sutures, implants, fasteners and/or bone anchors for treatingobstructive sleep apnea.

Description of the Related Art

In many surgical procedures, there is a need to pass a suture deep intotissue. Sometimes, a surgeon needs to pass a suture deep into tissue tosuspend the tissue by fixing the suture to bone. In particular, one suchsurgical procedure is suspension of tissues for treating conditions suchas obstructive sleep apnea (OSA).

Respiratory disorders during sleep are recognized as a common disorderwith significant clinical consequences. During the various stages ofsleep, the human body exhibits different patterns of brain and muscleactivity. In particular, the REM sleep stage is associated with reducedor irregular ventilatory responses to chemical and mechanical stimuliand a significant degree of muscle inhibition. This muscle inhibitionmay lead to relaxation of certain muscle groups, including but notlimited to muscles that maintain the patency of the upper airways, andcreate a risk of airway obstruction during sleep. Because musclerelaxation narrows the lumen of the airway, greater inspiratory effortmay be required to overcome airway resistance. This increasedinspiratory effort paradoxically increases the degree of airwayresistance and obstruction through a Bernoulli effect on the flaccidpharyngeal walls during REM sleep.

Obstructive Sleep Apnea (OSA) is a sleep disorder that affects up to 2to 4% of the population in the United States. OSA is characterized by anintermittent cessation of airflow in the presence of continuedinspiratory effort. When these obstructive episodes occur, an affectedperson will transiently arouse, regain muscle tone and reopen theairway. Because these arousal episodes typically occur 10 to 60 timesper night, sleep fragmentation occurs which produces excessive daytimesleepiness. Some patients with OSA experience over 100 transient arousalepisodes per hour.

In addition to sleep disruption, OSA may also lead to cardiovascular andpulmonary disease. Apnea episodes of 60 seconds or more have been shownto decrease the partial pressure of oxygen in the lung alveoli by asmuch as 35 to 50 mm Hg. Some studies suggest that increasedcatecholamine release in the body due to the low oxygen saturationcauses increases in systemic arterial blood pressure, which in turncauses left ventricular hypertrophy and eventually left heart failure.OSA is also associated with pulmonary hypertension, which can result inright heart failure.

Radiographic studies have shown that the site of obstruction in OSA isisolated generally to the supralaryngeal airway, but the particular siteof obstruction varies with each person and multiple sites may beinvolved. A small percentage of patients with OSA have obstructions inthe nasopharynx caused by deviated septums or enlarged turbinates. Theseobstructions may be treated with septoplasty or turbinate reductionprocedures, respectively. More commonly, the oropharynx and thehypopharynx are implicated as sites of obstruction in OSA. Some studieshave reported that the occlusion begins with the tongue falling back inan anterior-posterior direction (A-P) to contact with the soft palateand posterior pharyngeal wall, followed by further occlusion of thelower pharyngeal airway in the hypopharynx. This etiology is consistentwith the physical findings associated with OSA, including a large baseof tongue, a large soft palate, shallow palatal arch and a narrowmandibular arch. Other studies, however, have suggested that increasedcompliance of the lateral walls of the pharynx contributes to airwaycollapse. In the hypopharynx, radiographic studies have reported thathypopharyngeal collapse is frequently caused by lateral narrowing of thepharyngeal airway, rather than narrowing in the A-P direction.

OSA is generally diagnosed by performing overnight polysomnography in asleep laboratory. Polysomnography typically includeselectroencephalography to measure the stages of sleep, anelectro-oculogram to measure rapid eye movements, monitoring ofrespiratory effort through intercostal electromyography or piezoelectricbelts, electrocardiograms to monitor for arrhythmias, measurement ofnasal and/or oral airflow and pulse oximetry to measure oxygensaturation of the blood.

Following the diagnosis of OSA, some patients are prescribed weight lossprograms as part of their treatment plan, because of the associationbetween obesity and OSA. Weight loss may reduce the frequency of apneain some patients, but weight loss and other behavioral changes aredifficult to achieve and maintain. Therefore, other modalities have alsobeen used in the treatment of OSA, including pharmaceuticals,non-invasive devices and surgery.

Among the pharmaceutical treatments, respiratory stimulants and drugsthat reduce REM sleep have been tried in OSA. Progesterone, theophyllineand acetozolamide have been used as respiratory stimulants, but eachdrug is associated with significant side effects and their efficacy inOSA is not well studied. Protriptyline, a tricyclic antidepressant thatreduces the amount of REM sleep, has been shown to decrease thefrequency of apnea episodes in severe OSA, but is associated withanti-cholinergic side effects such as impotence, dry mouth, urinaryretention and constipation.

Other modalities are directed at maintaining airway patency duringsleep. Oral appliances aimed at changing the position of the softpalate, jaw or tongue are available, but patient discomfort and lowcompliance have limited their use. Continuous Positive Airway Pressure(CPAP) devices are often used as first-line treatments for OSA. Thesedevices use a sealed mask which produce airflow at pressures of 5 to 15cm of water and act to maintain positive air pressure within thepharyngeal airway and thereby maintain airway patency. Although CPAP iseffective in treating OSA, patient compliance with these devices is lowfor several reasons. Sleeping with a sealed nasal mask is uncomfortablefor patients. Smaller sealed nasal masks may be more comfortable topatients but are ineffective in patients who sleep with their mouthsopen, as the air pressure will enter the nasopharynx and then exit theoropharynx. CPAP also causes dry nasal passages and congestion.

Surgical treatments for OSA avoid issues with patient compliance and areuseful for patients who fail conservative treatment. One surgery usedfor OSA is uvulopalatopharyngoplasty (UPPP). UPPP attempts to improveairway patency in the oropharynx by eliminating the structures thatcontact the tongue during sleep. This surgery involves removal of theuvula and a portion of the soft palate, along with the tonsils andportions of the tonsillar pillars. Although snoring is reduced in amajority of patients who undergo UPPP, the percentage of patients whoexperience reduced frequency of apnea episodes or improved oxygensaturation is substantially lower. Postoperatively, many patients thathave undergone UPPP continue to exhibit oropharyngeal obstruction orconcomitant hypopharyngeal obstruction. Nonresponders often havephysical findings of a large base of tongue, an omega-shaped epiglottisand redundant aryepiglottic folds. UPPP is not a treatment directed atthese structures. UPPP also exposes patients to the risks of generalanesthesia and postoperative swelling of the airway that will require atracheostomy. Excessive tissue removal may also cause velo-pharyngealinsufficiency where food and liquids enter into the nasopharynx duringswallowing.

Laser-assisted uvulopalatopharyngoplasty (LAUP) is a similar procedureto UPPP that uses a CO₂ laser to remove the uvula and portions of thesoft palate, but the tonsils and the lateral pharyngeal walls are notremoved.

For patients who fail UPPP or LAUP, other surgical treatments areavailable but these surgeries entail significantly higher risks ofmorbidity and mortality. In genioglossal advancement with hyoid myotomy(GAHM), an antero-inferior portion of the mandible, which includes theattachment point of the tongue musculature, is repositioned forward andin theory will pull the tongue forward and increase airway diameter. Themuscles attached to the inferior hyoid bone are severed to allow thehyoid bone to move superiorly and anteriorly. Repositioning of the hyoidbone expands the retrolingual airspace by advancing the epiglottis andtongue base anteriorly. The hyoid bone is held in its new position byattaching to the mandible using fascia. Variants of this procedureattach the hyoid bone inferiorly to the thyroid cartilage.

A laser midline glossectomy (LMG) has also been tried in some patientswho have failed UPPP and who exhibit hypopharyngeal collapse onradiographic studies. In this surgery, a laser is used to resect themidline portion of the base of the tongue. This involves significantmorbidity and has shown only limited effectiveness.

In some patients with craniofacial abnormalities that include a recedingmandible, mandibular or maxillomandibular advancement surgeries may beindicated for treatment of OSA. These patients are predisposed to OSAbecause the posterior mandible position produces posterior tonguedisplacement that causes airway obstruction. In a mandibular advancementprocedure, the mandible is cut bilaterally posterior to the last molarand advanced forward approximately 10 to 14 mm. Bone grafts are used tobridge the bone gap and the newly positioned mandible is wire fixated tothe maxilla until healing occurs. Mandibular advancement may be combinedwith a Le Fort I maxillary osteotomy procedure to correct associateddental or facial abnormalities. These procedures have a high morbidityand are indicated only in refractory cases of OSA.

Experimental procedures described in the clinical literature for OSAinclude the volumetric radiofrequency tissue ablation and hyoidplasty,where the hyoid bone is cut into several segments and attached to abrace that widens the angle of the U-shaped hyoid bone. The latterprocedure has been used in dogs to increase the pharyngeal airway lumenat the level of the hyoid bone. The canine hyoid bone, however, isunlike a human hyoid bone because the canine hyoid bone comprises nineseparate and jointed bones, while the human hyoid bone comprises fivebones that are typically fused together.

Another surgical procedure performed to treat OSA is suture based tonguesuspension. However, current techniques for suture based tonguesuspension require the passage of suture through the tongue and into theoral space. This technique carries with it significant risks ofinfection as well as difficulty in accessing the optimal placement forthe suspension suture.

Notwithstanding the foregoing, there remains a need for improved methodsand devices for treating various conditions, including but not limitedto obstructive sleep apnea. There is also a need for improved devicesand methods for delivering suture into tissue. Specifically with respectto current methods for tissue suspension and compression, there is aneed to reduce infection risk due to suture exposure to the oral cavity,to improve the surgeon's range and ability to precisely locate andorient the suture, and to improve the ability of surgeons to properlytension the suture by eliminating the need to perform knot-tying whilesimultaneously controlling the final tension of the suture.

SUMMARY

The present disclosure provides suture passer system and methods fortissue suspension or compression.

In some embodiments, a suture passer is provided. The suture passer cancomprise a proximal handle. The suture passer can comprise an elongateshaft having a proximal end, a distal end, and a longitudinal axis. Thesuture passer can comprise a suture passing element coupled to thedistal end of the shaft. In some embodiments, the suture passing elementis movable with respect to the shaft, and configured to swivel withrespect to the shaft in an arc of at least about 90 degrees. In someembodiments, the suture passing element comprises a feature to engagethe suture. In some embodiments, the suture passing element comprises atube.

In some embodiments, a suture passer is provided. The suture passer cancomprise an elongate shaft. The suture passer can comprise a suturepassing element coupled to the elongate shaft. In some embodiments, thesuture passing element is configured to swivel with respect to theelongate shaft. The suture passer can comprise a second stage elementcarried within the suture passing element. In some embodiments, thesecond stage element can be configured to extend from and retract intothe suture passing element. In some embodiments, the second stageelement can be configured to exit an opening at or near a distal end ofthe suture passing element and form a path through tissue. The suturepasser can comprise a suture carried by the second stage element. Insome embodiments, the second stage element comprises a grasping elementoperably connected to the suture. In some embodiments, the graspingelement comprises a snare. In some embodiments, the grasping elementcomprises movable jaws.

In some embodiments, a suspension line is provided. The suspension linecan comprise a suture. The suspension line can comprise an overmoldedsegment. The suspension line can comprise a feature between the sutureand the overmolded segment which serves as a bearing.

In some embodiments, a method is provided. The method can include thestep of providing an implant having a first end and a second end. Themethod can include the step of securing the first end of the implant tothe palatopharyngeal arch. The method can include the step of tensioningthe implant. The method can include the step of securing the second endof the implant to a tissue selected from the group consisting of: thesuperior pharyngeal constrictor muscle, palatopharyngeal arch, andpalatoglossal arch.

In some embodiments, the implant comprises barbs. In some embodiments,the implant comprises suture loops. The method can include the step ofsecuring the implant to a bone anchor. The method can include the stepof adjusting the tension of the implant post-operatively.

In some embodiments, a method is provided. The method can include thestep of moving a portion of a tissue selected from the group consistingof: the superior pharyngeal constrictor muscle, palatopharyngeal arch,and palatoglossal arch. The method can include the step of securing afastener to a tissue selected from the group consisting of: the superiorpharyngeal constrictor muscle, palatopharyngeal arch, and palatoglossalarch.

In some embodiments, a method is provided. The method can include thestep of forming a loop around the hyoid bone. The method can include thestep of securing the loop to a bone anchor, wherein the bone anchor islocated on the mandible. In some embodiments, the loop is a girth hitch.In some embodiments, the loop is formed by an implant comprising alongitudinally extending tail and an implant head. In some embodiments,the implant comprises a ratchet for tensioning the loop.

In some embodiments, a method is provided. The method can include thestep of forming a hole in the hyoid bone. The method can include thestep of passing an implant through the hole in a collapsedconfiguration. The method can include the step of expanding the implantto an expanded configuration, wherein the implant is unable to passthrough the hole in the expanded configuration. In some embodiments, theimplant comprises expandable barbs.

In some embodiments, a suspension line for tensioning tissue isprovided. The suspension line can comprise a suture having a firstthickness dimension. The suspension line can comprise an elastomersurrounding a portion of the suture having a second thickness dimensiongreater than the first thickness dimension. The suspension line cancomprise at least one bearing element configured to allow the suture tomove with respect to the elastomer while maintaining the flexibility ofthe suture.

In some embodiments, the at least one bearing element is at leastpartially covered by the elastomer. In some embodiments, the at leastone bearing element comprises a knot. In some embodiments, the at leastone bearing element comprises a bead. In some embodiments, the at leastone bearing element comprises a coil. In some embodiments, the coilcomprises polypropylene. In some embodiments, the elastomer comprisessilicone. In some embodiments, the elastomer is at least partiallyradiopaque. In some embodiments, the elastomer is compounded with aradiopacifier.

In some embodiments, a suture passer is provided. The suture passer cancomprise a first section with a first distal tip and a first proximalhandle. The suture passer can comprise a second section with a seconddistal tip and a second proximal handle. The suture passer can comprisea slot on the sidewall of the first section. The suture passer cancomprise a first interior lumen extending through a portion of the firstsection and in communication with the slot. The suture passer cancomprise a plunger configured to enter the slot and the first interiorlumen and move a suture toward the second section.

In some embodiments, the plunger comprises a feature to engage thesuture. The suture passer can comprise a second interior lumen extendingthrough a portion of the second section. In some embodiments, theplunger is configured to enter the second interior lumen. In someembodiments, the second section comprises a snare. In some embodiments,the first section is configured to pivot relative to the second section.In some embodiments, the plunger comprises a head, wherein the head hasat least one dimension larger than a corresponding dimension of theplunger. In some embodiments, the first distal tip is curved. In someembodiments, the second distal tip is curved. In some embodiments, thefirst interior lumen is open at the first distal tip. In someembodiments, the second interior lumen is open at the second distal tip.

In some embodiments, a method of using a suture passer is provided. Themethod can include the step of providing a suture passer comprising afirst section with a first distal tip, a second section with a firstdistal tip, and a first interior lumen extending through a portion ofthe first section. The method can include the step of advancing thesuture passer around a hyoid bone. The method can include the step ofpassing a plunger into the first interior lumen.

The method can include the step of engaging the plunger with a suture.The method can include the step of engaging the suture with a snare. Themethod can include the step of engaging the suture with a feature of thesecond section. The method can include the step of disengaging thesuture as the plunger is retracted through the first interior lumen. Themethod can include the step of protruding the plunger from the firstinterior lumen toward the second distal tip. In some embodiments, thesuture passer comprises a second interior lumen extending through aportion of the second section, further comprising passing the plungerinto the second interior lumen. The method can include the step ofengaging the suture with a snare coupled to the second section. Themethod can include the step of engaging the suture with a featurecoupled to the second section. The method can include the step ofengaging a suture with the second section. The method can include thestep of advancing the plunger toward the suture. The method can includethe step of engaging the suture with the plunger. The method can includethe step of moving the suture through the first interior lumen as theplunger is retracted. The method can include the step of moving thesuture through the first interior lumen as the first section is pivoted.

In some embodiments, a method is provided. The method can include thestep of providing a suture having a first strand, a second strand, andan arc between the first strand and the second strand. The method caninclude the step of placing the arc on one side of the hyoid bone. Themethod can include the step of placing the first strand and the secondstrand on the other side of the hyoid bone. The method can include thestep of forming a girth hitch around the hyoid bone. The method caninclude the step of securing the first strand and the second strand to abone anchor. In some embodiments, the bone anchor is located on themandible. In some embodiment, the system further includes a secondsuture comprising a third strand, a fourth strand, and a second arcbetween the third strand and the fourth strand. The method can includethe step of coupling the third strand to the first strand. The methodcan include the step of pulling the third strand to form the girthhitch. The method can include the step of placing the second arc underthe first arc. The method can include the step of pulling the suturesuch that the second arc is on one side of the hyoid bone and both thethird and fourth strands are on other side of the hyoid bone. In someembodiments, the system further comprises an elastomer surrounding aportion of the suture. In some embodiments, the system further comprisesan at least one bearing element on the suture. In some embodiments, theat least one bearing element is at least partially covered by theelastomer.

In some embodiments, an apparatus is provided having a shaft for passinga suture and a needle coupled to the shaft. The needle is freelyrotatable with respect to the shaft. The needle can include a feature toengage the suture. The needle can include a tube. The apparatus can havea second stage element configured to extend from the needle.

In some embodiments, an apparatus is provided having a suture, anovermolded segment, and a feature between the suture and the overmoldedsegment which serves as a bearing.

In some embodiments, a method is provided which comprises the steps ofproviding an implant having a first end and a second end, securing thefirst end of the implant to the palatopharyngeal arch, tensioning theimplant, and securing the second end of the implant to a tissue selectedfrom the group consisting of: the superior pharyngeal constrictormuscle, palatopharyngeal arch, and palatoglossal arch. The implant caninclude barbs. The implant can include suture loops. The method caninclude the step of securing the implant with a bone anchor. The methodcan include the step of adjusting the tension of the suture loopspost-operatively.

In some embodiments, a method is provided which comprises the steps ofmoving a portion of a tissue selected from the group consisting of: thesuperior pharyngeal constrictor muscle, palatopharyngeal arch, andpalatoglossal arch; and securing a fastener to a tissue selected fromthe group consisting of: the superior pharyngeal constrictor muscle,palatopharyngeal arch, and palatoglossal arch.

In some embodiments, a method is provided which comprises the stepsforming a loop around the hyoid bone, and securing the loop to a boneanchor, wherein the bone anchor is located on the mandible. The loop canbe a girth hitch. The loop can be formed by an implant comprising alongitudinally extending tail and an implant head. The implant caninclude a ratchet.

In some embodiments, a method is provided which comprises the steps offorming a hole the hyoid bone; passing an implant through the hole in acollapsed configuration; and expanding the implant to an expandedconfiguration, wherein the implant is unable to pass through the hole.The implant can include expandable barbs.

Also disclosed herein is a suture passer comprising one or more of: aproximal handle; an elongate shaft having a proximal end, a distal end,a tubular body, and a longitudinal axis; a needle coupled to the distalend of the shaft, the needle having an arcuate deployed configuration,wherein the needle is movable with respect to the shaft, and configuredto swivel with respect to the shaft in an arc of at least about 90degrees; and a control on the proximal handle configured to swivel theneedle with respect to the shaft. The needle can comprise a feature toengage the suture, and comprise a tube in some embodiments.

In some embodiments, disclosed herein is a suture passer comprising oneor more of: a proximal handle having a first actuator control and asecond actuator control; a first elongate shaft extending distally fromthe handle; a first needle carried within the first elongate shaft, thefirst needle configured to extend from and retract into the firstelongate shaft, the first needle having a straight configuration whenlocated within the first elongate shaft, the first needle configured toexit an opening at or near a distal end of the first elongate shaft andform a curved or lateral path through tissue upon actuation of the firstactuator control; and a second needle carried within the first needle,the second needle configured to extend from and retract into the firstneedle, the second needle having a straight configuration when locatedwithin the first elongate shaft, the first needle configured to exit anopening at or near a distal end of the first needle and form a curved orlateral path through tissue upon actuation of the second actuatorcontrol, the second needle having an extended geometry that is differentfrom that of the first needle; and a suture carried by the secondneedle. The second needle can comprise a grasping element operablyconnected to the second needle, such as, for example, a snare or movablejaws.

Also disclosed herein is a suspension line comprising a suture; anovermolded segment; and a feature between the suture and the overmoldedsegment which serves as a bearing.

In another embodiment, disclosed is a method comprising providing animplant having a first end and a second end; securing the first end ofthe implant to the palatopharyngeal arch; tensioning the implant; andsecuring the second end of the implant to a tissue selected from thegroup consisting of: the superior pharyngeal constrictor muscle,palatopharyngeal arch, and palatoglossal arch. The implant can comprisesbarbs and/or suture loops. The implant can also be secured with a boneanchor. The tension of the suture loops can be adjusted during theprocedure, or post-operatively, such as 1 hour, 6 hours, 1 day, 1 week,1 month, or more post-operatively.

Also disclosed is a method comprising moving a portion of a tissueselected from the group consisting of: the superior pharyngealconstrictor muscle, palatopharyngeal arch, and palatoglossal arch; andsecuring a fastener to a tissue selected from the group consisting of:the superior pharyngeal constrictor muscle, palatopharyngeal arch, andpalatoglossal arch.

Also disclosed is a method comprising: forming a loop around the hyoidbone; and securing the loop to a bone anchor, wherein the bone anchor islocated on the mandible. The loop can be a girth hitch. The loop can beformed by an implant comprising a longitudinally extending tail and animplant head. The implant can also comprise a ratchet for tensioning theloop.

In some embodiments, disclosed is a method comprising: forming a hole inthe hyoid bone; passing an implant through the hole in a collapsedconfiguration; and expanding the implant to an expanded configuration,wherein the implant is unable to pass through the hole. The implant cancomprise expandable barbs.

Further disclosed herein is a suspension line for tensioning tissue,comprising: a suture having a first thickness dimension; a elastomersurrounding a portion of the suture and defining a central segment ofthe suspension line having a second thickness dimension greater than thefirst thickness dimension; and at least one bearing element on thecentral segment of the suspension line, the bearing element configuredto provide a rigid bearing to allow the suture to move with respect tothe elastomer (e.g., silicone) while maintaining the flexibility of thesuture. The at least one bearing element can be at least partiallycovered by the elastomer. The bearing element can include, for example,a knot, a bead, and/or a coil. The coil can comprise polypropylene, forexample. The elastomer can be at least partially radiopaque, and/orcompounded with a radiopacifier, such as barium sulfate for example.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1C illustrate an embodiment of a suture passer with a suturepassing element.

FIGS. 2A-2C illustrate a method of using the suture passer of FIG. 1A.

FIGS. 3A-3D illustrate an embodiment of a suture passer with a suturepassing element.

FIGS. 4A-4D illustrate embodiments of a suture passing element.

FIG. 5 illustrates the inability of a suture passer to reach a targetlocation.

FIGS. 6A-6C illustrate an embodiment of a suture passer with a secondstage element.

FIGS. 7A-7B illustrate an embodiment of a suture passer with a secondstage element.

FIGS. 8A-8B illustrate an embodiment of a suture passer with a secondstage element.

FIGS. 9A-9B illustrate an embodiment of a suture passer system with asecond stage element.

FIGS. 10A-10B illustrates an embodiment of a suture passer with a secondstage element.

FIGS. 11A-11E illustrate embodiments of a suture.

FIGS. 12A-12B illustrate a method of making a suture.

FIGS. 13A-D illustrates a method of delivering a plurality of sutureloops into tissue.

FIG. 14 illustrates a method of narrowing the lateral pharyngeal wall,according to one embodiment of the invention.

FIGS. 15A-15B illustrate the anatomy with and without an implant.

FIGS. 16A-16D illustrate an embodiment of a method of inserting animplant.

FIGS. 17A-17B illustrate an embodiment of an implant with a tissueingrowth portion.

FIGS. 18A-18B illustrate an embodiment of a method of inserting animplant.

FIGS. 19A-19E illustrate an embodiment of a method of inserting asuture.

FIG. 20 illustrates an embodiment of a method of inserting a suture.

FIGS. 21A-21B illustrate an embodiment of a method of using a boneanchor.

FIGS. 22A-22B illustrate an embodiment of an apparatus and method ofsecuring a tissue.

FIGS. 23A-23C illustrate embodiments of a fastener.

FIGS. 24A-24D illustrate an embodiment of a method of hyoid bonesuspension.

FIGS. 25A-25B illustrate an embodiment of a suture passer.

FIGS. 26A-26B illustrate an embodiment of a method of hyoid bonesuspension.

FIGS. 27A-27D illustrate an embodiment of a method of hyoid bonesuspension.

FIG. 28 illustrates an embodiment of a method of hyoid bone suspension.

FIGS. 29A-29C illustrate an embodiment of an implant and a method ofhyoid bone suspension.

FIG. 30 illustrates an embodiment of an implant.

FIG. 31 illustrates a method of hyoid bone suspension using an implant.

FIGS. 32A-32B illustrate an embodiment of an implant.

FIGS. 33A-33B illustrate an embodiment of an implant.

FIGS. 34A-34F illustrate an embodiment of a suture passer.

DETAILED DESCRIPTION

In some embodiment, disclosed is a suture passer system and method forpassing a suture (e.g., a suspension line, a tether, a tether loop, asuture, a suture loop, suture tape, an implant, etc.) through tissue tosuspend or compress the tissue. The term “suture” as used herein, unlessotherwise specified or limited, is intended to have its ordinary meaningand is also intended to include all structures, including any of theaforementioned or later-described examples, that can be passed throughtissue using the devices described herein.

As illustrated in FIG. 1A, the suture passer 100 can include a firstelongate tubular body or shaft 102. The shaft 102 can releasably coupleto a suture passing element 104. The suture passing element 104 can be aflexible needle. The suture passing element 104 can pass one, two, ormore sutures therethrough. Portions of the one or more sutures canreside outside of the first shaft 102. The distal end of the suturepassing element 104 can be sharpened to facilitate tissue penetration.In other embodiments, the distal end of the suture passing element 104can be blunt to prevent distal penetration through the mucosa, thuspreventing a through-and-through puncture. The shaft 102 can have alength of between about 4 cm to about 30 cm in some embodiments.

The suture passer 100 can include a second elongate tubular body orshaft (not shown). The second shaft can couple to a suture receivingelement (not shown). The suture receiving element can be a snare, forexample. The second shaft and the suture passer 100 can be substantiallysimilar to suture passer system described in commonly owned U.S. Pat.No. 8,460,322, the entire disclosure of which is incorporated byreference. The suture passer 100 can include any feature described in incommonly owned U.S. Pat. No. 8,460,322.

The shaft 102 can extend distally from a proximal handle 108. Asillustrated in FIG. 1A, the proximal end of the shaft 102 can be coupledto the handle 108. In some embodiments, the shaft 102 rotates when thehandle 108 rotates. The shaft 102 can rotate about the longitudinal axis114 of the proximal handle 108. In some embodiments, the shaft 102 canrotate independently from the handle 108. The shaft 102 can rotate aboutthe longitudinal axis 112 of the shaft 102.

As illustrated in FIG. 1A, the suture passing element 104 can be coupledto the distal end of the shaft 102. The suture passing element 104 canrotate relative to the distal end of the shaft 102. The shaft 102 caninclude one, two, or more slots or apertures 105 on the sidewall of thedistal end of the shaft 102. The suture passing element 104 can belocated within the slot 105. In some embodiments, the suture passingelement 104 is formed as an independent component from the shaft 102.The suture passing element 104 can rotate relative to the slot 105(e.g., 0°, 10°, 20°, 30°, 40°, 50°, 60°, 70°, 80°, 90°, 100°, 110°,120°, 130°, 150°, 160°, 170°, 180°, 190°, 200°, 210°, 220°, 230°, 240°,250°, 260°, 270°, 280°, 290°, 300°, 310°, 320°, 330°, 340°, 350°, 360°,at least 90°, at least 180°, at least 270°, etc., or a range includingany two of the foregoing values, such as between about 0° and about 180°for example).

The suture passing element 104 can function as a hook. The suturepassing element 104 can be moved in position relative to the shaft 102.The shaft 102 can be rotated relative to the suture passing element 104after the suture passing element 104 hooks, or passes an elongateelement around a bone. The suture passing element 104 can rotate whenthe shaft 102 is held stationary. The shaft 102 can rotate when thesuture passing element 104 is held stationary. The suture passingelement 104 and the shaft 102 can rotate at the same time, in the samedirections and/or orientations or a different directions and/ororientations. The suture passing element 104 can rotate relative to thelongitudinal axis 112 of the shaft 102. The suture passing element 104can rotate relative to the longitudinal axis 114 of the proximal handle108. The suture passing element 104 can rotate about an axis 116,wherein axis 116 is perpendicular to the longitudinal axis 112 of theshaft 102. The suture passing element 104 can rotate about one, two, ormore axes. In some embodiments, the suture passing element 104 whilerotating in an arc, offset from the longitudinal axis of the shaft 102,during at least one point during rotation the path of the arc intersectsthe longitudinal axis 112 of the shaft 102. The degree of rotation ofthe suture passing element 104 can be, in some embodiments, at leastabout 45°, 90°, 135°, 180°, 225° or more, or between about 90° and 180°,135-225°, or different ranges including two of the foregoing valuesthereof for example.

The suture passing element 104 can include a longitudinal axis 118. Insome orientations, the longitudinal axis 118 of the suture passingelement 104 is aligned with the longitudinal axis 112 of the shaft 102,as shown in FIGS. 1A and 2A. In some orientations, the longitudinal axis118 of the suture passing element 104 is not aligned with thelongitudinal axis 112 of the shaft 102, as shown in FIGS. 1B, 1C, and 2Cas well as the schematic of FIG. 1C clarifying certain features. Thesuture passing element 104 can be rotated relative to the slot 105 asshown in FIG. 1C.

In some embodiments, a mechanism (not shown) can control the rotation ofthe suture passing element 104 relative to the shaft 102. The mechanism110 can be housed within the shaft 102. The suture passing element 104can be coupled to the shaft 102. The suture passing element 104 can beretained in the slot 105. The slot 105 can include a bushing 120 orother device known in the art to permit free rotation. The distal end ofthe shaft 102 can be split to house the bushing 120. A component 130such as a fastener can couple the split distal end of the shaft 102 toprevent the disengagement and/or loosening of the bushing 120. In someembodiments, the bushing 120 provides friction to hold the suturepassing element 104 relative to the shaft 102. The torque exerted byrotating the shaft 102 can rotate the shaft 102 relative to the suturepassing element 104.

As illustrated in FIGS. 2A-2C, a method of using the suture passer 100is shown with respect to the hyoid bone. The method illustrates agenerally superior to inferior approach. The longitudinal axis 118 ofthe suture passing element 104 can be generally aligned with thelongitudinal axis 112 of the shaft 102. The suture passing element 104can extend from the distal end of the shaft 102. The shaft 102 can bemanipulated relative to the hyoid bone until the suture passing element104 surrounds, such as least partially circumscribes a portion of thehyoid bone. FIG. 2B illustrates the front view of the approach. As shownin FIGS. 2A-2B, the longitudinal axis 118 of the suture passing element104 is aligned with the longitudinal axis 112 of the shaft 102. Thesuture passing element 104 can hook or otherwise pass an elongateelement such as a suture around the hyoid bone. The shaft 102 can berotated relative to the suture passing element 104 and/or the suturepassing element 104 can be rotated relative to the shaft. FIG. 2Cillustrates the suture passing element 104 in a position after acompleted pass in some embodiments. The shaft 102 is rotated relative tothe suture passing element 104 a different position relative to thehyoid bone. The longitudinal axis 118 of the suture passing element 104is not aligned with the longitudinal axis 112 of the shaft 102.

As illustrated in FIGS. 3A-3D, the suture passing element 104 can rotaterelative to the shaft 102. This can be completed by an internalmechanism to actively rotate the suture passing element 104, overcomingfrictional forces between the shaft 102 and the suture passing element104. The suture passing element 104 can be coupled to the shaft 102 viathe bushing 120. The suture passing element 104 can rotate in an arcabout, or at least about 15 degrees, 30 degrees, 60 degrees, 90 degrees,105 degrees, 120 degrees, 135 degrees, 150 degrees, 165 degrees, 180degrees, 195 degrees, 210 degrees, 225 degrees or more relative to theaxis 116. The axis 116 can be transverse to the longitudinal axis 112 ofthe shaft 102.

The suture 106 can be carried by the suture passing element 104 andthereby passed around the hyoid bone. As illustrated in FIG. 4A, thesuture 106 can form a suture loop including a first strand 106A, asecond strand 106B and an arc (e.g., loop portion) 106C connected to andresiding between the first strand 106A and the second strand 106B. Thearc 106C can form a portion of a circle. The suture 106 can bepre-attached to the suture passing element 104 prior to the suturepassing element 104 being passed around the hyoid bone. In otherembodiments, the suture 106 can be attached to the suture passingelement 104 after the suture passing element 104 is passed around thehyoid bone. The suture 106 can be passed around the hyoid bone as thesuture passer 100 is retracted. The suture 106 can remain in place,around the hyoid bone, after the suture passer 100 is retracted.

As illustrated in FIGS. 4A-4D, the suture passing element 104 can have avariety of configurations. As shown in FIGS. 4A-4C, a portion of thesuture passing element 104 can include one or more suture engagementmechanisms. As shown in FIG. 4A, the suture engagement mechanism can bea slot 124. The suture 106 can be inserted into the slot 124. Forinstance, the first strand 106A, the second strand 106, and/or the arc106C can be inserted into the slot. The insertion of the arc 106C intothe slot 124 and around the hyoid bone may facilitate the tying of aknot, as described herein. As shown, the slot 124 can be a lateral slotextending through the suture passing element 104. The suture 106 can beinserted so that the arc 106C is on one side of the suture passingelement 104 and the first strand 106A and the second strand 106B of thesuture 106 are on the other side of the suture passing element 104.

As shown in FIG. 4B, the suture engagement mechanism can be a pluralityof holes 126, 126′ (e.g., two or more holes). While two holes are shown,other configurations are contemplated (e.g., three, four, five, six,etc.). The first strand 106A of the suture 106 can be inserted into afirst hole 126, and the second strand 106B of the suture 106 can beinserted into a second hole 126′. As shown, the holes 126, 126′ can belaterally-facing (or alternatively distal-facing) holes with respect tothe distal end of the suture passing element 104. The holes 126, 126′can extend through the suture passing element 104. The suture 106 can beinserted so that the arc 106C is on one side of the suture passingelement 104 and the first strand 106A and the second strand 106B of thesuture 106 are on the other side of the suture passing element 104.

As shown in FIG. 4C, the suture engagement mechanism can be a notch 128.The suture 106 can be inserted into the notch 128. As shown, the notch128 can be a lateral notch extending along a surface of the suturepassing element 104. The arc 106C of the suture 106 can be inserted intothe notch 128. The first strand 106A is on one side of the suturepassing element 104 and the second strand 106B is on the other side ofthe suture passing element 104. The slot 124, the holes 126, and thenotch 128 can be formed in a distal end of the suture passing element104. The suture 106 can be coupled to the suture passing element 104before or after passing the suture passing element 104 is passed arounda bone or tissue. In some methods, the suture engagement mechanism canguide the suture 106 around the bone or tissue.

As shown in FIG. 4D, the suture engagement mechanism can be a lumen 130.In some embodiments, the lumen 130 extends through a portion of theentire length of the suture passing element 104. The lumen 130 caninclude a distally-facing exit aperture, as opposed to thelaterally-facing suture engagement mechanisms described with respect toFIGS. 4A-4C. The lumen 130 can extend the entire length of the suturepassing element 104. The lumen 130 can extend along the length of thecurved longitudinal axis 118 of the suture passing element 104. In otherwords, the suture passing element 104 can be in the form of a tubularstructure.

In some embodiments, the suture passing element 104 includes a secondstage element 132 as shown in FIG. 6A. The second stage element 132 canbe movable within the central lumen 130 as illustrated in FIG. 4D. Thesecond stage element 132 can be coaxial with the suture passing element104. The suture passing element 104 allows for the passage of the secondstage element 132 through the suture passing element 104. As shown inFIG. 5, the suture passing element 104 may be unable to reach a targetlocation 302. The suture passing element 104, in some embodiments, doesnot penetrate the soft tissue 300. In some cases, this limitation iscaused by the interference of the shaft 102 with the soft tissue 300. Insome cases, this limitation is caused by the geometry of the suturepasser 100 and/or the geometry of the patient's anatomy.

This limitation has been observed, for example, in some cases whenattempting to pass the suture passing element 104 close to the backside(e.g., posterior surface) of a body structure such as a bone 200, suchas the hyoid bone for example. The bone 200 can be located deep withinan incision. The bone 200 can be surrounded by soft tissue 300. A suturepassing element 104 that is agile enough to start the pass whilemaintaining proximity to the bone 200 may not be sufficiently longenough to penetrate the soft tissue on the opposing side of the bone 200to reach the target location 302. In other words, the need for agilityof the suture passing element 104 may limit the length of the suturepassing element 104. In other words, the design constraints of thesuture passer 100 may prevent the suture passing element 104 fromreaching the target location 302.

The second stage element 132 can be deployed to reach the targetlocation 302, as shown in FIG. 6A. The second stage element 132 can bedeployed through the lumen 130 of the suture passing element 104. Thesuture passer 100 with the second stage element 132 can penetrate thesoft tissue 300 after passing around the bone 200. The suture passer 100with the second stage element 132 can form a complete pass (e.g., aloop) around the bone 200.

As shown in FIGS. 6A-6B, the second stage element 132 can extenddistally beyond, and from a distal end of the suture passing element104. The second stage element 132 can be a linear extension of thedistal end of the suture passing element 104. As shown in FIGS. 6A-6C, atool 134 can be used to pass the second stage element 132 through thesuture passing element 104. The tool 134 can insert the second stageelement 132 into the lumen 130 of the suture passing element 104. Insome embodiments, the second stage element 132 can be inserted into thesuture passing element 104 at the proximal end of the suture passingelement 104. In some embodiments, the second stage element 132 can beinserted into the suture passing element 104 at the location where thesuture passing element 104 couples with the shaft 102.

The second stage element 132 can include a needle 136, as shown in FIG.6B. The needle 136 facilitates the additional tissue penetration toreach the target location 302. The second stage element 132 can includea suture engagement mechanism to engage suture 106. The sutureengagement mechanisms can include those shown in FIGS. 4A-4D. Forinstance, the distal end of the second stage element 132 can include aslot, one or more holes, a notch, or a lumen or other feature.

As shown in FIGS. 7A-7B, the second stage element 132 can include asnare 137. The snare 137 can extend through the lumen 130 of the suturepassing element 104 as described herein. FIG. 7A shows the snare 137retracted and FIG. 7B shows the snare 137 advanced from the distal endof the suture passing element 104. The snare 137 creates a larger targetfor the user to place the suture 106. In other words, the snare 137 maybe, in some embodiments, easier to thread with the suture 106 than thesuture engagement mechanisms such as the slot, the holes, and the notch,shown in FIGS. 4A-4D.

As shown in FIGS. 8A-8B, the second stage element 132 can includefeatures of FIGS. 6A-6B and 7A-7B. The second stage element 132 caninclude both a needle 140 and a snare 142. The needle 140 facilitatesthe additional tissue penetration to reach the target location 302. Thesnare 142 creates a larger target for the user to place the suture 106in the suture passer 100. The snare 142 can be operably attached to theneedle 140 as illustrated, such as via laterally-facing apertures in theneedle 140. FIG. 8A shows the second stage element 132 in a retractedconfiguration and FIG. 8B shows the second stage element 132 in anextended configuration and advanced from the distal end of the suturepassing element 104.

As shown in FIGS. 9A-9B, the second stage element 132 can be a grasper144 having a plurality of movable jaws. The grasper 144 can beconfigured to hold one or more sutures 106 when the grasper 144 isretracted. FIG. 9A shows the grasper 144 retracted. FIG. 9B shows thegrasper 144 advanced from the distal end of the suture passing element104. In some embodiments, the grasper 144 can open when deployed fromthe distal end of the suture passing element 104, releasing the sutures106. The sutures 106 can be coupled to the grasper 144 and/or the suturepasser 100 prior to the suture passer 100 advancing around the bone 200.In some embodiments, the grasper 144 can close around the sutures 106and transport the sutures 106 around the bone 200. The grasper 144 canbe retracted into the suture passing element 104.

In some embodiments, the suture passing element 104 can have a complexconfiguration having a plurality of distal curved regions havingdiffering radii of curvature, such as a first region having a firstradii of curvature, and a second region having a second radii ofcurvature that is greater or less than the first radii of curvature. Thefirst region and the second region can have convex curves, concavecurves, or one convex and the other concave in some embodiments. FIGS.10A-10B show a coiled suture passing element 148, resembling a pig'stail. The coiled suture passing element 148 can have any combination ofthe characteristics described herein with reference to suture passingelement 104. The coiled suture passing element 148 can be tubular. Thecoiled suture passing element 148 can include a second stage element132. The second stage element 132, such as a needle, facilitates theadditional tissue penetration to reach the target location 302. Thesecond stage element 132, such as a snare, can create a larger targetfor the user to place the suture 106. The second stage element 132, suchas grasper, can hold or release sutures 106 during the pass.

In some embodiments, the outer or inner diameter of the shaft of thesuture passer 100 can be between about ⅜ inch and about 1 inch. Thediameter can be selected based upon the method to be performed. Theouter or inner diameter of the suture passing element 104 and the coiledsuture passing element 148 can be, for example, between about 1/16 inchand about ⅛ inch for methods for passing a suture around the hyoid bone.

The diameter rod or tube used to make the suture passing element 104 candepend on a number of factors. In some embodiments, it may be desirableto have the suture passing element 104 that is stiff. For instance, thesuture passing element 104 may need to be stiff enough to penetratetissue, such as tough connective tissues around the hyoid bone. Thesuture passing element 104 may need to be large enough to accommodatefeatures described herein, such as suture engagement mechanisms. Thesuture passing element 104 may need to be large enough to accommodateadditional components, such as the second stage element 132. It may bedesirable to design the suture passer 100 as small as possible, forinstance, with as small diameter as possible. A small diameter mayminimize the amount of injury to the tissue. The diameter of secondstage element 132 can be, for example between about 1/16 inch and about⅛ inch for methods for passing a suture around the hyoid bone.

In some embodiments, the suture passing element 104 is subjected totorque. For instance, the suture passing element 104 may be subjected totorque loads when pushed through connective tissue. It can beadvantageous, in some embodiments, to minimize deformations that occurwhen the suture passing element 104 is subjected to torque, load and/orforce. The suture passing element 104 may be sufficiently stiff tonavigate through connective tissue. The suture passing element 104 canbe formed, in some embodiments, from a material (e.g., stainless steel)that has adequate characteristics to resist deformation during theintended use. The second stage element 132 can be formed, in someembodiments, from a material that is super-elastic (e.g., nitinol).

FIGS. 11A-11E illustrate various embodiments of sutures 106. The suturesdescribed herein can include a variable-thickness suspension line forsuspending tissue, including a suture 106 having a first thicknessdimension. The suture described herein can include an elastomersurrounding a portion of the suture forming an overmolded segment 150and defining a central segment of the suspension line having a secondthickness dimension greater than the first thickness dimension. Theelastomer can be overmolded onto the suture 106. The elastomer can be,for example silicone. The suture 106 can be braided. The elastomer canbe overmolded over a plurality of discontinuous segments of the suture106. The central segment of the suspension line can include one or moreknots and/or one or more beads for improving adhesion between the sutureand the elastomer. The suspension line could have a rounded, and/or arectangular cross-section. As such, the sutures can either be elastic orinelastic. In some embodiments, elastic sutures can be stretched to atleast about 110%, 120%, 130%, 140%, 150%, 175%, 200%, 250%, 300%, ormore of their unstretched length.

The suture 106 can include at least one transition zone extending fromthe central segment of the suspension line to a lateral end of thesuspension line, the transition zones having a thickness dimension thattapers from the second thickness dimension to the first thicknessdimension. The suture 106 can have any features described in commonlyowned U.S. patent application Ser. No. 14/020,617, the disclosure ofwhich is incorporated by reference herein.

The suture 106 can be a #2 suture, or any other size depending on thedesired clinical result (e.g., #1 to #6). The suture 106 can be formedfrom a suitable material (e.g., braided polyester, braidedpolyethylene). The suture 106 can include a longitudinal sutureoptionally coupled with additional features. The suture 106 can includetwo free ends. The suture 106 can include one, two, or more sections ofincreased thickness, that can be overmolded segments 150, or otherwiseattached over the suture 106 to increase thickness of the suture. Theovermolded segment 150 can be formed from, for example, silicone orother elastomer. The overmolded segment 150 can be silicone compoundedwith a radiopacifier, such as barium sulfate, and as such be radiopaqueunder an imaging modality, such as fluoroscopy or CT. In otherembodiments, the suture, e.g., the overmolded segment 150, or a portionthereof is visible under other imaging modalities, such as ultrasoundfor example. As the suture 106 stretches under load, the overmoldedsegment 150 will move and stretch with the suture 106, and canadvantageously provide a bearing against wear in some cases.

FIG. 11A shows a suture 106 with a series of spaced-apart knots 152, orareas of increased width and/or surface area. The knots 152 can beoverhand knots in some embodiments. The longitudinal suture 106 can beknotted to form an integral structure. The series of knots 152 increaseadhesion between the suture 106 and the overmolded segment 150.

FIG. 11B shows a suture 106 with a suture braid 154. The suture braid154 can be formed with the longitudinal first suture 106 and a secondsuture 106′ having the same size (e.g., #2) or a different (e.g., largeror smaller) size (e.g., #5) with respect to the size of the longitudinalfirst suture 106. The second suture 106′ is braided with thelongitudinal first suture 106 and forms a suture sock as shown. The endsof the second suture 106′ can be fixed to the longitudinal first suture106 to prevent fraying. In some embodiments, heat is used to fix thesecond suture 106′ to the longitudinal first suture 106. The suturebraid 154 provides some bulk to the overmolded segment 150. The suturebraid 154 can serve as a bearing.

FIG. 11C shows a suture 106 with a series of beads 156. The beads 156can be rigid or flexible beads. The beads 156 can be formed from asuitable material (e.g., glass). The beads 156 can all have the samediameter, as shown in FIG. 11C. The beads 156 can be retained on thelongitudinal suture 106 by knots 152 positioned at the end of the beads156. The knots 156 can be overhand knots. The knots 152 can be adjacentto the first and last beads 156 or spaced apart from the first and lastbeads 156. The beads 156 can serve as a rigid bearing, and in someembodiments advantageously allow the suture 106 to slide, stretch, orotherwise move within the overmolded segment 150. The beads 156 allowthe suture 106 to remain flexible due to the discrete nature of thebeads 156.

FIG. 11D shows a suture 106 with a series of beads 158. The beads 158can have varying diameters as illustrated in FIG. 11D. The beads 158 canbe formed from a suitable material (e.g., glass). The suture 156 canhave similar characteristics as suture 158. The beads 158 can havedifferent diameters. The diameter of the beads 158 can be selected toaccommodate the shape of the overmolded segment 150. The suture 106 canhave two differing diameters of beads 158. The smaller diameter beads158 can be located near the suture ends, and the larger diameter beads158 can be located between the smaller diameter beads 158, or in adifferent arrangement.

FIG. 11E shows suture 106 with a coil 160. The coil 160 can be formedfrom a suitable material (e.g., a polymer (e.g., polypropylene), suture,(e.g., #2 or other size monofilament suture), or a metal (e.g.,stainless steel)). The coil 160 can be wrapped around the longitudinalsuture 106. The coil 160 can be threaded around the longitudinal suture106. The coil 160 can be retained on the longitudinal suture 106 byknots 152 positioned at the end of the coil 160. The knots 152 can beoverhand knots. The knots 152 can be adjacent to the ends of the coil160 or spaced apart from the ends of the coil 160. The coil 160 canserve as a bearing. The coil 160 can allow the suture 106 to slide,stretch, or otherwise move within the overmolded segment 150. The coil160 allows the suture 106 to remain flexible. The coil 160 of suture 106may be more flexible than the beads 156, 158 of sutures shown in FIG.11C-11D.

FIG. 12A shows an embodiment of the suture 106 before overmolding. FIG.12B shows the suture 106 after overmolding, with overmolded segment 150.The length, suture size, and/or overall diameter of the coil 160 can beadjusted depending on the desired clinical result. The coil 160 ofsuture 106 may be advantageously relatively simple to manufacture. Thelength, suture size, and/or overall diameter of the overmolded segment150 can be adjusted depending on the desired clinical result. Theovermolded segment 150 of suture 106 may be advantageously relativelysimple to manufacture.

In some embodiments, the suture 106 and/or suture 106′ could be USP #2,or about 0.020″ or less in diameter. In some embodiments, the sectionsof increased thickness, e.g., the overmolded sections 150, could bebetween about 0.080″ to 0.120″, or 0.020″ to 0.030″×0.080″ to 0.120″. Insome embodiments, the lengths of the overmolded sections 150 could bebetween about 2 cm and about 3 cm. The suture 106 with the overmoldedsection 150 could also include a tapered thickness or diameter section,such as parts of the overmolded sections 150. The length of the tapercould be, for example, less than 1 cm, or less than 0.5 cm. In someembodiments, the first suture 106 could be USP #3, or about 0.024″ orless in diameter. In some embodiments, the overmolded sections 150 couldbe between about 0.030″ to 0.200″, or 0.020″ to 0.030″×0.030″ to 0.200″,or have a diameter that it at least about 20%, 30%, 40%, 50%, 60%, 75%,100%, 125%, 150%, 200%, or more larger than that of the underlyingsuture 106 without overmolding. In some embodiments, the lengths of theovermolded sections 150 could be between about 1 cm and about 5 cm. Thelength of the taper on either side of the overmolded section 150 orlargest diameter/thickest section could be up to about 20%, 30%, 40%, or50% of the length of the overmolded section 150 or entire largediameter/thickest section. In some embodiments, additional suture 106and other features that can be used or modified for use with embodimentsdisclosed herein can be found, for example, in U.S. patent applicationSer. No. 14/020,617 to Feezor et al., which is hereby incorporated byreference in its entirety.

The surface of any of the disclosed sutures may be mechanically,chemically, or otherwise modified to improve adhesion with, for example,muscle cells and other tissues of the genioglossus. Mechanicalmodifications create improved adhesion by modifying the surface textureof the implant and may be achieved as part of the manufacturing processand may involve the removal of material from, or the addition ofmaterial to the surface of the implant. Chemical adhesion may beachieved through the incorporation of chemical (including biological)compounds into the surface or the bulk material or materials that makesup the implant in order to improve the affinity between cellularcomponents and the implant. Compounds may include, but are not limitedto proteins, peptides, antibodies, growth factors, or other moleculeswhich create an affinity for cellular or tissue components.

FIGS. 13A-13D illustrate a method of narrowing the lateral pharyngealwall. Some surgical procedures indirectly tension the lateral pharyngealwall. The technique involves a plurality, e.g., two, three, or moresuture passes around the superior pharyngeal constrictor muscle. Thesutures are sewn into the palatoglossal muscle and tied off as shown.The aforementioned technique can require exposure of muscle with severalincisions in the mucosa layer, and the technical ability to consistentlyanchor the suture in the superior pharyngeal constrictor muscle. Thetechnique can also require the ability to consistently anchor the suturein the palatoglossal muscle. In some cases, there may be increased painand recovery time for patients due to the mucosal incisions.

In some embodiments, as illustrated in FIG. 14, a barbed implant 162 canbe utilized. The barbed implant 162 can include a first end 164 and asecond end 166. The first end 164 can include one or more barbs. Thesecond end 166 can include one or more barbs. The barbs on the first end164 can point in a first direction away from the second end 166. Thebarbs on the second end 166 can point in a second direction away fromthe first end 164. In other embodiments, the barbs can point in the samedirection. The barbed implant 162 can have a longitudinally extendingportion between the first end 164 and the second end 166. In someembodiments, the longitudinally extending portion does not include barbsas shown in FIG. 14. In other embodiments, the longitudinally extendingportion includes barbs. The barbed implants 162 can be elastic orinelastic. The longitudinally extending portion can be elastic orinelastic. The barbs can generally move in one direction (e.g., to beinserted into tissue). The barbs resist movement in an oppositedirection (e.g., to prevent back out of the barbed implant 162).

The system can include one or a plurality (e.g., about or at least about2, 3, 4, 5, 6, or more) of barbed implants 162. The barbs can functionas proximal and/or distal anchors. The barbed implant 162 can beimplanted into tissue 300. The barbed implant 162 can be horizontallyoriented within the body of the patient. The method of use can includean implant inserter tool 168. The implant inserter tool 168 can includea proximal handle, an elongate shaft, and a distal tip. The barbedimplant 162 can be implanted by advancing an implant inserter tool 168in a generally horizontal orientation. The implant inserter tool 168 canrelease the barbed implant 162 into the tissue 300. In some embodiments,the barbed implants 162 could be implanted within about 10 degrees ofthe horizontal axis. However, in other embodiments, the barbed implants162 could be within less than about 15 degrees, 30 degrees, 45 degrees,60 degrees, 75 degrees of the horizontal axis. This provides morelocalized control of tissue suspension, depending on the desiredclinical result.

In some methods of use, a combination of generally horizontally-orientedbarbed implants 162 can be used as shown in FIG. 14. In some methods ofuse, a combination of generally horizontally oriented barbed implants162 and generally vertically-oriented barbed implants 162 can be used.In some methods of use, a combination of generally vertically-orientedbarbed implants 162 can be used. In some embodiments, the distancebetween barbed implants 162 could be irregular or regular. The distancebetween the midlines of the barbed implants 162 could be, for example,between about 0.1 cm and about 3 cm. The barbed implants 162 can havethe same or different orientations within the tissue 300. In someinstances where additional suture strength is required at a singlelocation within tissue, the multiple barbed implants 162 may share amidline axis, but be oriented differently (from −90 to +90 degrees) fromeach other.

FIG. 14 illustrates three barbed implants 162 deployed in the tissue300. As shown, the barbed implants 162 are used to tack the superiorpharyngeal constrictor muscle to the palatoglossal muscle. The barbedimplants 162 may extend from the palatoglossal arch to thepalatopharyngeal arch. The barbed implants 162 may each include alongitudinal extending section, the first end 164 and the second end166, as described herein. The barbs of the first end 164 may be orientedthe same as, or differently from the barbs on the second end 166. Thebarbs on the first end 164 may be opposite the orientation of the barbson the second end 166. The barbs may be configured to engage tissue 300when tensioned from different directions.

FIGS. 15A-15B illustrates a cross-sectional view of the palatoglossalarch and the palatopharyngeal arch. FIG. 15A shows the barbed implant162 deployed. The barbed implant 162 compresses the palatopharyngealarch toward the palatoglossal arch. FIG. 15B illustrates across-sectional view of the anatomy without the barbed implant 162. Thebarbed implant 162 can be deployed at an angle relative to thehorizontal. The angle may be approximately 45 degree. The angle can bedetermined by the relative anatomy of the patient.

FIGS. 16A-D illustrate a method of inserting the barbed implant 162.FIG. 16A shows the implant inserter tool 168 having the proximal handle,the elongate shaft, and the distal tip. The implant inserter tool 168can be inserted into and extends between the palatoglossal arch and thepalatopharyngeal arch. The implant inserter tool 168 can be advanceduntil the distal tip is proximate a target location. FIG. 16B shows thebarbed implant 162 being deployed from the distal tip of the implantinserter tool 168. This can be accomplished, for example, by actuating acontrol on the proximal handle to actuate a pushrod distally, forexample to expel the barbed implant 162. The first end 164 of the barbedimplant 162 engages tissue 300 of the palatopharyngeal arch. In someembodiments, the barbs may further embed in the tissue 300 as a force isapplied to the barbed implant 162. The barbs of the barbed implant 162dig into or otherwise embed in the soft tissue 300. The tool 168 isretracted from the palatopharyngeal arch.

FIG. 16C shows the tool 168 being retracted to the palatoglossal arch.By applying a force (e.g., tension) on the barbed implant 162, the barbsmay further embed in the tissue 300. The palatopharyngeal arch may bebrought toward the palatoglossal arch. The palatopharyngeal arch may becompressed against the palatoglossal arch. In some embodiments, thepalatopharyngeal arch may touch the palatoglossal arch. Thepalatopharyngeal arch may be pulled laterally and/or anteriorly.

FIG. 16D shows the implant inserter tool 168 being retracted from thepalatoglossal arch. The second end 166 of the barbed implant 162 engagestissue 300 of the palatoglossal arch. The barbed implant 162 may bedeployed such that the first end 164 engages the palatopharyngeal archand the second end 166 engages the palatoglossal arch. As force isapplied to the barbed implant 162, the barbs may further embed into thesoft tissue 300, thereby inhibiting further movement of the barbedimplant 162. The method steps shown in FIGS. 16A-16D can be repeated todeploy one or more barbed implants 162 on one or more sides of theairway.

In some cases, the method can include several advantages depending onthe desired clinical result. The technique can leave the mucosa layerintact. The barbed implants 162 can be anchored to a larger tissue areathan the sutures, in some embodiments. The technique is a simple,repeatable process providing dependable results. The technique mayproduce a large clinical benefit for minimally invasive intervention.

FIGS. 17A-17B illustrate embodiments of the barbed implant 162 withtissue ingrowth material 170. The tissue ingrowth material 170 may belocated near the first end 164. The tissue ingrowth material 170 may belocated near the second end 166. The tissue ingrowth material 170 may belocated near the first end 164 and near the second end 166. The tissueingrowth material 170 may be located beyond the first end 164. Thetissue ingrowth material 170 may be located beyond the second end 166.The tissue ingrowth material 170 may be located beyond the first end 164and beyond the second end 166. The tissue ingrowth material 170 mayprovide long-term stability of the barbed implant 162. The tissueingrowth material 170 may prevent migration of the barbs out of thetissue. The tissue ingrowth material 170 can be biocompatible, toprevent rejection of the barbed implant 162 by the body of the patient.The tissue ingrowth material 170 and may include one or more drugs orother therapeutic agents.

FIGS. 18A-18B illustrate a method of inserting the barbed implant 162.FIG. 18A shows the implant inserter tool 168 inserted into thepalatopharyngeal arch. The implant inserter tool 168 is advanced untilthe distal tip is located at a target location. FIG. 18A shows thebarbed implant 162 being deployed from the distal tip of the implantinserter tool 168. The barbed implant 162 engages tissue 300 of thepalatopharyngeal arch. In some embodiments, the barbs may further embedin the tissue as a force is applied to the barbed implant 162. The barbsof the barbed implant 162 dig into or otherwise embed in the softtissue. The implant inserter tool 168 is retracted from thepalatopharyngeal arch. FIG. 18B shows the implant inserter tool 168retracted. The barbed implant 162 spans from the palatopharyngeal archto the base of the palatoglossal arch. The barbed implant 162 compressesthe palatoglossal arch. By applying a force (e.g., tension) on thebarbed implant 162, the barbs may further embed in the tissue. Thepalatopharyngeal arch may be brought toward the palatoglossal arch. Thepalatopharyngeal arch may be pulled laterally. This technique avoidstacking the palatopharyngeal arch directly to the palatoglossal arch.

FIGS. 19A-19E illustrate a method of inserting a suture 106 for a tissuelift procedure. The suture 106 can include the overmolded segment 150 asdescribed herein. FIG. 19A shows the method step of making an incisionin the skin of the head of a patient. FIG. 19B shows the method step ofmaking a small surgical dissection pocket. FIGS. 19C-19E show variousnon-limiting possible suture passes. Path A provides neck lift, Path Bprovides mid-level cheek lift, and Path C provides eye line lift, asshown in FIG. 19C. Path D, as shown in FIG. 19D, shows the path whereinthe suture passes inferiorly to the mandible. The suture is advanceduntil reaching the midline of the neck. The method may include the stepof placing suspension sutures such as suture 106 with the overmoldedsegment 150 under the jaw line. Path E, as shown in FIG. 19E illustratesthe path of suture 106 forming loops in the neck. The method may includethe step of suspending a suture, trimming extra skin, and/or closing theincision. The sutures may be placed using the SMAS, or the sub-muscularaponeurotic system. The system and methods, such as the use of varioussuture passers, can be as disclosed herein and can be, or modified fromsystems and methods described in U.S. Pat. No. 8,460,322, the entiredisclosure of which is incorporated by reference.

FIG. 20 illustrate a method of inserting a suture 106. The suture 106can include the overmolded segment 150 as described herein. The methodscan be performed by a suture passer described herein and in commonlyowned U.S. Pat. No. 8,460,322, the entire disclosure of which isincorporated by reference. The suture passer can be modified, (e.g.,reduced in size). The suture passer can be used to place suture 106. Thesuture 106 can form loops within the tissue instead of single shortsections of suture. The suture passer can place suture 106 into thesuperior pharyngeal constrictor muscle. The suture 106 can be placed asshown. The suture 106 can be placed near the palatopharyngeal arch, thepalatoglossal arch and/or any location between the palatopharyngeal archand the palatoglossal arch. The suture 106 can be anchored. The suture106 can be anchored into palate tissue and/or the hard palate. Thesuture 106 can be tensioned to stabilize the lateral pharyngeal wall.The method can in some embodiments narrow the lateral pharyngeal walland/or provide the lateral pharyngoplasty.

FIGS. 21A-21B illustrate a method of using one or more bone anchors 172in an adjustable tensioning system. The bone anchors 172 can be knotlessbone anchors in some embodiments. The suture 106 can be inserted intothe bone anchors 172. In some embodiments, the suture 106 includes afirst strand 106A, a second strand 106B and an arc connecting the firststrand 106A and the second strand 106B. The first strand 106A has a freeend and the second strand 106B has a free end. The free ends of thesuture 106 can be inserted into a lumen of the bone anchor 172. The boneanchor 172 can be tightened to secure the first strand 106A and thesecond strand 106B. The bone anchor 172 can be loosened to release thefirst strand 106A and the second strand 106B and allow for adjustabletensioning without necessarily requiring untying of the suture loop.

The bone anchors 172 can be used to secure the suture 106 within theface or neck, or another desired anatomical location. The suture 106 canform a loop such that the suture arc 106C is disposed within the tissue.The sutures 106 may be placed to provide a face and/or neck lift.

The bone anchor 172 can provide post-operative adjustability to thesuture 106. For instance, the suture 106 can be adjusted after the arcs106C are placed, during the procedure and/or at any time in the future.The suture 106 could be adjusted days, months, or years after the suture106 is placed within the body. The bone anchor 172 permits adjusting thesuture 106 by increasing or decreasing tension in a minimally invasivemanner. In some embodiments, the bone anchor 172 can selectively releasethe first strand 106A. In some embodiments, the bone anchor 172 canselectively release the second strand 106B. In some embodiments, thebone anchor 172 can selectively release the first strand 106A and thesecond strand 106B. The surgeon can apply tension to the first strand106A and/or the second strand 106B. Once adjusted, the bone anchor 172can be tightened to retain the first strand 106A and the second strand106B. The bone anchor 172 permits adjusting the face and/or neck lift ina minimally invasive manner. The free ends of the suture 106 may bepulled, slid, tensioned and/or manipulated to adjust the suture 106.This movement would then adjust the tissue, bone, and/or skin coupled tothe suture 106 (e.g., adjust the face and neck lift).

The bone anchor 172 can have lock and unlock capabilities. The boneanchor 172 can include an opening (e.g., a hexagonal opening) for theinsertion of a tool (not shown). The tool can lock and unlock the boneanchor 172, allowing for the suture 106 to be adjusted. The bone anchor172 may be implanted on a surface of the skin and/or within the body.The bone anchor 172 can be placed above the ear (e.g., in the temporalbone), as shown in FIG. 21A. The bone anchor 172 can be placed under theskin near the ear, as shown in FIG. 21B. The bone anchor 172 placedunder the skin can be adjusted by making a small incision near the boneanchor 172. The incision may be near the implantation location for thebone anchor 172. The tool can be inserted into the incision to adjustthe bone anchor 172.

FIGS. 22A-22B illustrate a tool 176 and method for moving the superiorpharyngeal constrictor or another desired muscle. The tool 176 can movethe superior pharyngeal constrictor muscle in any direction (e.g.,laterally and/or anteriorly). The tool 176 can stabilize the superiorpharyngeal constrictor muscle in the desired location (e.g., laterallyand/or anteriorly). The tool 176 can insert a fastener 178 (e.g., atack, staple, cap, suture loop, or suture). The fastener 178 can bebiodegradable or bioabsorbable in some cases. The tool 176 can include ablunt tip for moving the tissue. The tool 176 can couple to the fastener178 for stabilizing the tissue. FIG. 22A shows the tool 176 moving thesuperior pharyngeal constrictor muscle laterally. The tool 176 can movethe superior pharyngeal constrictor muscle via the blunt tip. Thesuperior pharyngeal constrictor muscle may be moved toward the side ofthe airway. The tool 176 can be positioned to discharge (e.g., launch,fire) the fastener 178 to stabilize the tissue. The method can berepeated for the contralateral side of the airway to move the superiorpharyngeal constrictor muscle laterally.

FIGS. 23A-23C illustrate some embodiments of the fastener 178, with theplacement of the fastener 178 shown in relation to the superiorpharyngeal constrictor muscle. FIG. 23A shows the fastener 178 as astaple, with ends biased toward each other. FIG. 23B shows the fastener178 as a tack, having a proximal tissue contacting structure and adistal tissue contracting structure, both operably connected to atension element. FIG. 23C shows the fastener 178 as the suture 106. Thesuture 106 can form a loop by bringing the first end 106A to the secondend 106B. The suture 106 can be stabilized with anchors as describedherein. The suture 106 can be placed with a device like a suture passeras described herein. The fastener 178 can be a barbed suture 162, asshown in FIG. 14 for example. The fastener 178 can be bioabsorbable insome embodiments. The fastener 178 can extend from the superiorpharyngeal constrictor muscle to a location near the palatopharyngealarch, the palatoglossal arch and/or any location between thepalatopharyngeal arch and the palatoglossal arch. The fastener 178 canextend from the fascia behind the superior pharyngeal constrictormuscle.

FIGS. 24A-24D illustrate a method of hyoid suspension. The hyoid bone islocated in the anterior midline of the neck and is anchored by muscles.The hyoid aids in tongue movement and swallowing. Hyoid suspensioninvolves pulling the hyoid forward in order to increase the size of theairway. FIG. 24A illustrates the method step of forming an incision inthe neck of a patient. The incision can be, for example, between 2 cmand 4 cm. The incision may extend from, for example, the hyoid bone tothe mandible. The surgeon can dissect the tissue and muscle to reach thehyoid bone.

FIG. 24B illustrates the method step of using a suture passer for hyoidsuspension. The method may utilize a suture passer substantially similarto the systems and methods described herein or in commonly owned U.S.Pat. No. 8,460,322, the entire disclosure of which is incorporated byreference. The suture passer can be used to pass a suture loop 106around the body of the hyoid bone. The suture 106 can include theovermolded segment 150. The suture 106 has the first strand extendinglongitudinally 106A, the second strand extending longitudinally 106B,and the arc 106C connecting the first strand 106A and the second strand106B. The arc 106B is passed around the hyoid bone. The suture loop 106can be elastic or inelastic. The suture 106 can be substantially similarto the sutures described herein, including the sutures shown in FIGS.11A-12B. The arc 106C can be on one side of the hyoid bone. The first106A and second strand 106B can be on the other side of the hyoid bone.In some methods, the first strand 106A and the second strand 106B arethen passed around the hyoid bone. The first strand 106A and the secondstrand 106B are passed under the arc 106B. The suture 106 can form agirth hitch. Other knot configurations are contemplated. For instance,the suture 106 could be wrapped around the hyoid bone forming aklemhiest or prusik knot.

The first suture 106 can be replaced with a second, larger suture 108.The larger suture 108 can include be a larger diameter suture,suspension loop, suture tape, etc. The larger suture 108 can be similarto suture 106. The larger suture 108 can prevent erosion through thebone. The second, larger suture 108 can be elastic. The larger suture108 can include the overmolded segment 150 as described herein. Thesuture 108 has a first strand extending longitudinally 108A, a secondstrand extending longitudinally 108B, and an arc 108C connecting thefirst strand 108A and the second strand 108B.

In some methods of use, the first strand 106A is passed around the hyoidbone. The arc 106C can be in contact with the hyoid bone. The secondstrand 106B can be on the other side of the hyoid bone. The suture 106can be used to place the suture 108, akin to a guide suture. In somemethods, the arc 108C can be placed around the first strand 106A. Thearc 108C can be operably coupled to the first strand 106A. The suture106 can be pulled. In some embodiments, the second strand 106B of thesuture 106 is pulled. The arc 108C can be on one side of the hyoid bone.The first 108A and second strand 108B can be on the other side of thehyoid bone. In some methods, the first strand 108A and the second strand108B are then passed around the hyoid bone. The first strand 108A andthe second strand 108B are passed under the arc 108B. The suture 108 canform a girth hitch. Other knot configurations are contemplated. Forinstance, the suture 108 could be wrapped around the hyoid bone forminga klemhiest or prusik knot.

In some methods of use, the arc 106C is passed around the hyoid bone asshown in FIG. 24C. The arc 106C is on one side of the bone and the firststrand 106A and the second strand 106B can be on the other side of thehyoid bone. In some methods, the arc 108C can be placed under the arc106C. The suture loop 106 can be pulled. In some embodiments, the firststrand 106A and the second strand 106B of the suture 106 are pulled. Thearc 108C can be on one side of the hyoid bone. The first 108A and secondstrand 108B can be on the other side of the hyoid bone. In some methods,the first strand 108A and the second strand 108B are then passed aroundthe hyoid bone. The first strand 108A and the second strand 108B arepassed under the arc 108B. The suture 108 can form a girth hitch. Otherknot configurations are contemplated. FIG. 24C shows the method ofpulling the larger suture 108, which can be operably connected to thesmaller guide suture 106 in some embodiments.

FIG. 24D illustrates the method step of securing the suture 106 and/orlarger suture 108 to the mandible. The method may utilize a bone anchor178, which can include any or all of the features of bone anchor 178described herein. The bone anchor 178 can be a knotless bone anchor. Thebone anchor 178 can be a locking bone screw. The loop of the suture 106and/or larger suture 108 provides a knotless attachment to the hyoidbone.

The tension, position, and/or suspension of the hyoid bone can beadjusted by adjusting the loop of the suture 106 and/or larger suture108. For instance, pulling on the first strand 106A and/or the secondstrand 106B can change the position of hyoid bone. For instance,changing the location of the suture 106 relative to the hyoid bone canchange position of the hyoid bone.

The bone anchor 178 can allow for post-operative adjustment of thesuture 106 and/or larger suture 108. The bone anchor 178 can release thefirst strand 108A and or the second strand 108B. The surgeon can adjustthe tension provided by the first strand 108A and the second strand108B. The larger suture 108 can be adjusted after the knot is placed,and/or at any time in the future. The larger suture 108 could beadjusted days, months, years after the larger suture 108 is placedwithin the body. The larger suture 108 can be adjusted acutely orchronically. The method of passing the suture 106, 108 around the hyoidbone may be simpler, easier, and more minimally invasive than using acurved needle. Although FIG. 24D shows one larger suture 108, more thanone larger suture 108 can be utilized (e.g., two girth hitch knots,three girth hitch knots, etc.). The thickness, strength, and/or othermaterial properties may be selected to minimize the number of largersutures 108. A single larger suture 108 of a sufficiently thick and/orstrong material may be able to stabilize the hyoid bone with respect tothe mandible.

FIG. 25A-25B illustrate a suture passer, in particular the distal end ofthe suture passer. The suture passer 182 can be modified from the suturepasser described in commonly owned U.S. Pat. No. 8,460,322, the entiredisclosure of which is incorporated by reference. The suture passer 182can be modified to include one or more sharpened suture passing needles184. The sharper needles 184 may be configured for passing throughtissues having a greater inherent resistance to puncture, such asligaments (e.g., hyoepiglottic ligaments, hypothyroid ligaments). Thedesign and/or material of the needle 184 may be selected to enhancestiffness.

The suture passer 182 can be modified to include one or more sharp tips186. The sharp tips 186 on the ends of the suture passer 182 may beuseful in passing through ligaments as noted above. The suture passer182 can include a depth stop 188 which may limit the forward movement ofthe suture passer 182. The depth stop 188 may serve as a safety measure,to prevent the suture passer 182 from puncturing the airway.Alternatively, the tips could be blunt and atraumatic in someembodiments.

FIG. 25B illustrates the placement of the suture passer 182 within thebody of the patient. The sharp tips 186 may surround the hyoid bone. Theneedle 184 may penetrate the hyoepiglottic ligament. The needle 184 mayextend from one sharp tip 186 to the other sharp tip 186 in order topass the suture. Surrounding structures such as the hyothryoid ligament,thyroid cartilage, and epiglottis are also shown for reference.

FIG. 26A-26B illustrate a method of hyoid bone suspension. FIG. 26Aillustrates the method step of forming a girth hitch around the hyoidbone. FIG. 26A utilizes two sutures 106 (e.g., #2 suture, suture tape(e.g., 2 mm suture tape)). One, two, or more girth hitch knots may beutilized as shown in FIG. 26A. The first strand 106A and the secondstrand 106B pass under the arc 106C. The first strand 106A and thesecond strand 106B of the suture 106 are secured to a bone anchor 178.The bone anchor 178 can be located on the mandible. The bone anchor 178can be tightened to securely hold the first strand 106A and the secondstrand 106B. The bone anchor 178 can be loosened to release the firststrand 106A and the second strand 106B. The surgeon can alter thetension applied to the hyoid bone. The bone anchor 178 can be tightenedafter the adjustment. FIG. 26A shows a configuration with twoside-by-side girth hitch knots, and two bone anchors 178. FIG. 26B showsa configuration with one girth hitch knot illustrated using suture tape,and three bone anchors 178. Additional girth hitch knots utilizingsutures 106 may be utilized in FIG. 26B with respect to the remainingbone anchors 178. The ratio of girth hitches or other knots to boneanchors 178 may be greater than 1:1 (2 girth hitches to 1 bone anchors)or equal to 1:1 (2 girth hitches to 2 bone anchors) in some embodiments.The ratio of sutures 106 to bone anchors 178 may be greater than 1:1 (2girth hitches to 1 bone anchors) or equal to 1:1 (2 girth hitches to 2bone anchors) in some embodiments.

FIG. 27A-27D illustrates a method of forming a girth hitch, in someembodiments. The suture 106 includes the first strand 106A, the secondstrand 106B, and the arc 106C. FIG. 27A shows the method step ofconducting a pass with a suture passer. The suture 106 may be folded,held or otherwise coupled to the suture passer. FIG. 27B shows themethod step of retracting the suture passer and/or the needle of thesuture passer. The arc 106C remains within the body. FIG. 27Cillustrates passing the first strand 106A and the second strand 106B ofthe suture 106 through the arc 106C of the suture 106 to form a girthhitch. FIG. 27D illustrates the method step of tensioning the firststrand 106A and the second strand 106B of the suture 106 to form a girthhitch. The first strand 106A and the second strand 106B of the suture106 can be coupled to a bone anchor 178 as described herein. The boneanchor 178 can be attached to the mandible. The suture 106 may be eitherpre-attached to the bone anchor 178 prior to the procedure, or followingformation of the girth hitch. The suture 106 can be a smaller diameterguide suture. In some methods, the suture 106 can be coupled with alarger diameter suture 108, which can follow the path of the guidesuture 106 to create a girth hitch. In some methods, the arc 108C of thelarger diameter suture 108 can be passed under the arc 106C of thesuture 106C to create a girth hitch.

The method illustrated in FIG. 27A-27D illustrates the creation of agirth hitch around the hyoid bone at the midline (e.g., near themidline, substantially near the midline). The girth hitch may beconnected to a bone anchor 178. The bone anchor 178 may be attached tothe mandible at the midline (e.g., near the midline, substantially nearthe midline).

Alternatively two girth hitch knots may be deployed. The girth hitchknots may be coupled to the hyoid bone. The two girth hitch knots can bearound the hyoid bone. The two girth hitch knots can be placed on eitherside (e.g., right side, left side) of the midline of the hyoid bone, asshown in FIGS. 26A and 28. In some embodiments, the two girth hitchknots can be coupled to two bone anchor 178. The two bone anchors 178can be placed on either side (e.g., right side, left side) of themidline of the mandible, as shown in FIG. 26A. In some embodiments, thetwo girth hitch knots can be coupled to a single bone anchor 178. Thesingle bone anchor 178 can be placed at the midline of the mandible(e.g., near the midline, substantially near the midline), as shown inFIG. 28. The single bone anchor 178 can be placed on either side (e.g.,right side, left side) of the midline of the hyoid bone.

FIGS. 29A-29C illustrate an embodiment of a hyoid suspension implant 192(e.g., an alternative to, or can be combined with the suture). FIG. 29Aillustrates an implant 192. The implant 192 can include an implant head192A, that can have a relatively larger width dimension, and alongitudinally extending tail 192B having a relatively smaller widthdimension. The implant head 192A includes a slot or other featuredesigned to accept the longitudinally extending tail 192B. FIGS. 29B-29Cshow a method of using the implant 192. The implant 192 can be passedbehind the hyoid bone. The implant head 192A is passed around the hyoidbone. The longitudinally extending tail 192B can be passed through theslot in the implant head 192A. The longitudinally extending tail 192B istensioned. The implant 192 wraps around the hyoid bone, as shown in FIG.29C. In some methods, the longitudinally extending tail 192B is passedaround the hyoid bone. The longitudinally extending tail 192B can bepassed through the slot in the implant head 192A. The longitudinallyextending tail 192B can be tensioned. The implant 192 wraps around thehyoid bone, as shown in FIG. 29C.

The implant head 192A, including the slot, and/or the longitudinalextending tail 192B can have additional features. The implant caninclude a locking mechanism. The locking mechanism can be a ratchetformed within or on the implant head 192A, the slot, and/or thelongitudinal extending tail 192B. The locking mechanism can lock theimplant 192 against the hyoid bone once the implant 192 has beentensioned. FIG. 30 shows an embodiment of the locking mechanism,surrounding a cross-section of a body structure, such as the hyoid bone.The longitudinally extending tail 192B includes teeth and/or ratchetsthat engage the slot. The slot includes teeth and/or ratchets thatengage the longitudinally extending tail 192B. The locking mechanismlocks the implant 192 in place after the implant 192 has been tensioned.The bone anchors 178 can also include teeth and/or ratchets that engagethe longitudinally extending tail 192B. The longitudinally extendingtail 192B can include teeth and/or ratchets that engage the bone anchor178. The teeth and/or ratchet can provide a knotless method of lockingthe implant to the bone anchor.

The implant 192 can be manufactured from a biocompatible material (e.g.,plastic). The implant 192 can be formed from any process (e.g., braidingsuture). The teeth and/or ratchet can be formed into the implant (e.g.,crimped into the suture). The teeth and/or ratchet can take any shape(e.g., balls, triangular teeth, and/or slits).

FIG. 31 illustrates a method of attaching an implant to a hyoid bone.The method can include the step of drilling a small hole in the hyoidbone (e.g., a through hole). The implant 194 can be passed through thehole. The implant 194 can be reduced in diameter in order to fit throughthe small hole. The implant 194 can have a collapsed configuration andan expanded configuration. The implant 194 can be passed through thehole in the collapsed configuration. The implant 194 can be expanded tothe expanded configuration after passing through the small hole. In theexpanded configuration, the implant 194 cannot pass through the hole.For instance, the implant 194 can have a generally T-shapedconfiguration as shown in FIG. 31. The T-shape prevents the implant 194from passing through the hole in the hyoid bone. A suture 106 (e.g.,suture, suture tape) can be attached to the implant 194. The implant 194can include a longitudinally extending tail 194B. The suture 106 can becoupled to the longitudinally extending tail 194B. The longitudinallyextending tail 194B can be disposed within the hole. The suture 106and/or longitudinally extending tail 194B can be connected to the boneor tissue (e.g., mandible, thyroid cartilage).

The implant 194 can be constructed from a material suitable forexpanding (e.g., super elastic metal or plastic). The implant 194 can beconstrained in the collapsed configuration, having a small diameter fordelivery and/or insertion into the hole. The implant 194 can beconstrained by a sheath. The implant 194 is allowed to expand oncedelivered and/or once the restraint is removed. The expandedconfiguration has a larger diameter than the collapsed configuration.

FIGS. 32A-32B illustrates a method of attaching an implant to a hyoidbone. The method can include the step of drilling a small hole in thehyoid bone (e.g., a through hole). The implant 195 can be passed throughthe hole. The implant 195 can have a reduced diameter configuration inorder to fit through the small hole. The implant 195 can have acollapsed configuration and an expanded configuration. The implant 195can be passed through the hole in the collapsed configuration. Theimplant 195 can be expanded to the expanded configuration after passingthrough the small hole. In the expanded configuration, the implant 195cannot pass through the hole. FIGS. 32A-32B illustrate an embodiment ofthe implant 195. The implant 195 can include barbs 196. For instance,the barbs 196 can have a generally J-shaped configuration as shown inFIG. 32B. The J-shape prevents the implant 195 from passing through thehole in the hyoid bone. The barbs 196 can be formed from a materialsuitable for expanding (e.g., super elastic metal or plastic). FIG. 32Ashows the barbs 196 in the collapsed configuration. The barbs 196 can beconstrained by a sheath. The barbs 196 can be constrained by the smallhole. The implant 195 can be coupled to a suture 106. FIG. 32B shows thebarbs 196 in the expanded configuration. The sheath has been removed.The barbs 196 can have a larger diameter preventing the barbs 196 frompassing back through the small hole.

FIG. 33A-33B illustrates a method of attaching an implant to a hyoidbone. The method can include the step of drilling a small hole in thehyoid bone (e.g., a through hole). The implant 197 can be passed throughthe hole. The implant 197 can be reduced in diameter in order to fitthrough the small hole. The implant 197 can have a collapsedconfiguration and an expanded configuration. The implant 197 can bepassed through the hole in the collapsed configuration. The implant 197can be expanded to the expanded configuration after passing through thesmall hole. In the expanded configuration, the implant 197 cannot passthrough the hole. FIGS. 33A-33B illustrate an embodiment of the implant197. The implant 197 can include a suture 198. The implant 197 can havea collapsed configuration wherein the suture 198 extends along alongitudinal axis. The implant 197 can have an expanded configurationwherein the suture 198 forms a suture ball. FIG. 33A shows the implant197 in the collapsed configuration. The suture 198 can be constrained bya sheath. The suture 198 can be constrained by the small hole. FIG. 33Bshows the implant 197 in the expanded configuration. The suture 198 canhave a larger diameter preventing the implant 197 from passing backthrough the small hole. The implant 197 can be coupled to suture 106.The implant 197 and/or the suture 106 may be coupled to a bone or tissue(e.g., mandible).

FIGS. 34A-34F illustrate an embodiment of a suture passer 200. Thesuture passer 200 can include a first section 202. The first section 202can include a first handle 204. The first section can include a firsttip 206. The first section 202 can be coupled to a second section 208.The first section 202 can be joined with, for example, a pivot pin tothe second section 208 akin to a scissors tool. The second section 208can include a second handle 210. The second section 208 can include asecond tip 212.

The first tip 206 can form a jaw. The second tip 212 can form a jaw. Thejaw can be curved. The jaw can include serrations or other features toimprove grip to the bone or other tissue. The curvature of the jaw canallow the first tip 206 to surround a portion of a body structure, suchas the hyoid bone. In some embodiments, the first tip 206 surroundsapproximately 180 degrees of the hyoid bone. In some embodiments, thefirst tip 206 surrounds greater than 180 degree of the hyoid bone,approximately 270 degrees of the hyoid bone, greater than 270 degrees ofthe hyoid bone, etc. The curvature of the jaw can allow the second tip212 to surround a portion of the hyoid bone. In some embodiments, thesecond tip 212 surrounds approximately 180 degrees of the hyoid bone. Insome embodiments, the second tip 212 surrounds greater than 180 degreeof the hyoid bone, approximately 270 degrees of the hyoid bone, greaterthan 270 degrees of the hyoid bone, etc. The first tip 206 and thesecond tip 212 can surround the entire hyoid bone or a substantialportion thereof.

The assembly can include a plunger 216. The plunger 216 can include ahead 214. The head 214 can have an enlarged cross-sectional area. Thehead 214 can guide the plunger 216. The plunger 216 can be flexibleand/or elastic. As shown in FIG. 34B, the first section 202 can includea slot 218, either distal or proximal to the pivot. The slot 218 can besized to accept the plunger 216. The slot 218 can be smaller than thediameter of the head 214 to limit the head 214 from passing through theslot 218. The slot 218 can be located on the opposite side of the pivotas the first handle 204. The slot 218 can be tapered. The slot 218 canextend from a surface 220 of the first section 202 to an interior lumen222 of the first section 202 as described herein.

The plunger 216 can include a suture engagement mechanism. The sutureengagement mechanism can be similar to the suture engagement mechanismsdescribed herein for example with references to FIGS. 4A-4D. The sutureengagement mechanism can include slots, holes, notches or lumens toengage the suture 106. The plunger 216 can engage the suture 106 to passthe suture 106.

As shown in FIG. 34C, the second tip 212 can include an interior lumen224. The interior lumen 224 can be sized to accept the plunger 216. Insome embodiments, the second section 208 can include a slot (not shown).The slot on the second section 208 can be substantially similar to slot218. The slot can be located on the opposite side of the pivot as thesecond handle 210. The slot on the second section 208 can be tapered.The slot on the second section 208 can extend from a surface of thesecond section 208 to the interior lumen 224 of the second section 202.

The interior lumen 222 of the first section 202 and the interior lumen224 of the second section 202 can be aligned when the first tip 206 andthe second tip 212 are brought together as shown in FIG. 34B. Theinterior lumens 222, 224 can form a continuous channel for the plunger216 between the proximal slot opening on a sidewall and thedistal-facing tip opening. The interior lumen 222 of the first section202 is open at the first tip 206. The interior lumen 224 of the secondsection 208 is open at the second tip 212. This allows the plunger 216to pass between the first section 202 and the second section 208.

As shown in FIG. 34D, the suture passer 200 is advanced toward the hyoidbone. The suture passer 200 can be passed through a submental incision.The first tip 206 can be pivoted to surround the hyoid bone. The secondtip 212 can be pivoted to surround the hyoid bone. The first tip 206 andthe second tip 212 can be pivoted separately or simultaneously. Thefirst tip 206 can be pivoted by actuating the handle 204. The second tip212 can be actuated by pivoting the handle 210. The tips 206, 212 arebrought toward each other. In some embodiments, the tips 206, 212 touch.In some embodiments, the tips 206, 212 are in close proximity. In someembodiments, a small gap is formed between the first tip 206 and thesecond tip 212. The interior lumen 222 of the first section 202 and theinterior lumen 224 of the second section 208 are aligned when the tips206, 212 are brought together. In some methods, the action of closingthe tips 206, 212 stabilizes the suture passer 200 against the hyoidbone.

FIG. 34E shows that the plunger 216 can enter the slot 218 of the firstsection 202. The plunger 216 can be guided by the head 214. The plunger216 can enter the interior lumen 222 of the first section 202. Theplunger 216 can be advanced toward the interior lumen 224 of the secondsection 208. The plunger 216 can enter the interior lumen 224 of thesecond section 208. In some methods, the plunger 216 can exit the slotin the second section 208 (not shown). The head 214 can abut the surface220 when the plunger 216 reaches the slot in the second section 208. Theenlarged cross-section of the head 214 can prevent the head 214 fromentering the slot 218. In other techniques, the plunger 216 enters theslot in the second section 208 and exits the slot 218 of the firstsection 202.

FIG. 34F show a cross-sectional view of the first section 202. The slot218 can be tapered in some embodiments. The interior lumen 222 can alignwith the interior lumen 224. The interior lumens 222, 224 can be sizedto accept the plunger 216. The plunger 216 can be advanced until itprotrudes from the interior lumen 222. The plunger 216 can span the gapbetween the first tip 206 and the second tip 212. In other embodiments,the plunger 216 extends from the interior lumen 222 directly into theinterior lumen 224. The plunger 216 can include a sharpened tip 228 topenetrate any tissue within the gap. The plunger 216 can bridge anypotential gap between the first tip 206 and the second tip 212.

In some techniques, the second tip 212 can engage the suture 106 carriedby the plunger 216. The second tip 212 can include a snare or otherfeature to engage the suture 106. The second tip 212 can unload thesuture 106 from the plunger 216 as the plunger 216 is retracted. In sometechniques, the plunger 216 is retracted with the first tip 206.

In some techniques, the second tip 212 engages the suture 106. Theplunger 216 could include a snare or other feature to engage the suture106. The plunger 216 can be advanced through the first tip 202 towardthe suture 106. The plunger 216 would engage the suture 106 from thesecond tip 212. The plunger 216 can engage the suture 106 as the plunger216 enters the interior lumen 224 of the second tip 212. The plunger 216can be retracted to pull the suture 106 through the first tip 206.

It is contemplated that various combinations or subcombinations of thespecific features and aspects of the embodiments disclosed above may bemade and still fall within one or more of the inventions. Further, thedisclosure herein of any particular feature, aspect, method, property,characteristic, quality, attribute, element, or the like in connectionwith an embodiment can be used in all other embodiments set forthherein. Accordingly, it should be understood that various features andaspects of the disclosed embodiments can be combined with or substitutedfor one another in order to form varying modes of the disclosedinventions. Thus, it is intended that the scope of the presentinventions herein disclosed should not be limited by the particulardisclosed embodiments described above. Moreover, while the invention issusceptible to various modifications, and alternative forms, specificexamples thereof have been shown in the drawings and are hereindescribed in detail. It should be understood, however, that theinvention is not to be limited to the particular forms or methodsdisclosed, but to the contrary, the invention is to cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the various embodiments described and the appended claims.Any methods disclosed herein need not be performed in the order recited.The methods disclosed herein include certain actions taken by apractitioner; however, they can also include any third-party instructionof those actions, either expressly or by implication. For example,actions such as “passing a suture to suspend the hyoid bone” include“instructing the passing of a suture to suspend the hyoid bone.” Theranges disclosed herein also encompass any and all overlap, sub-ranges,and combinations thereof. Language such as “up to,” “at least,” “greaterthan,” “less than,” “between,” and the like includes the number recited.Numbers preceded by a term such as “approximately”, “about”, and“substantially” as used herein include the recited numbers (e.g., about10%=10%), and also represent an amount close to the stated amount thatstill performs a desired function or achieves a desired result. Forexample, the terms “approximately”, “about”, and “substantially” mayrefer to an amount that is within less than 10% of, within less than 5%of, within less than 1% of, within less than 0.1% of, and within lessthan 0.01% of the stated amount.

1.-64. (canceled)
 65. A method comprising: securing a bone anchor to amandible; providing a suture line having a first segment, a secondsegment, and an arc between the first segment and the second segment;forming a girth hitch around a hyoid bone by passing the first segmentand the second segment through the arc; adjusting a tension of thesuture line by pulling the first segment and the second segment throughthe bone anchor; and locking the suture line to the bone anchor.
 66. Themethod of claim 65, wherein the suture line is at least partiallyradiopaque.
 67. The method of claim 65, further comprising passing thesuture line around the hyoid bone with a suture passer instrument. 68.The method of claim 65, further comprising forming a girth hitch aroundthe hyoid bone with a second suture line.
 69. The method of claim 65,further comprising securing a second bone anchor to the mandible. 70.The method of claim 65, further comprising adjusting a tension of asecond suture line.
 71. The method of claim 65, further comprisinglocking a second suture line to a second bone anchor.
 72. A methodcomprising: securing a bone anchor to a mandible; positioning a curvedsuture passing element of a suture passing instrument around a hyoidbone; using the suture passing instrument to pass a suture line aroundthe hyoid bone; forming a girth hitch around the hyoid bone by passing afirst segment and a second segment of the suture line through an arc ofthe suture line; and securing the first segment and the second segmentto the bone anchor.
 73. The method of claim 72, wherein using the suturepassing instrument comprises rotating the curved suture passing elementrelative to the hyoid bone.
 74. The method of claim 72, furthercomprising forming a girth hitch around the hyoid bone with a secondsuture line.
 75. The method of claim 74, further comprising securing thesecond suture line to a second bone anchor.
 76. The method of claim 75,wherein the girth hitch formed from the suture line is formed on a rightside of a midline of the hyoid bone and the girth hitch formed from thesecond suture line is formed on a left side of the midline of the hyoidbone.
 77. The method of claim 76, wherein the bone anchor is secured toa right side of a midline of the mandible, and the second bone anchor issecured to a left side of the midline of the mandible.
 78. The method ofclaim 72, wherein forming the girth hitch around the hyoid bone furthercomprises forming the girth hitch at a midline of the hyoid bone. 79.The method of claim 72, wherein the bone anchor is secured at a midlineof the mandible.
 80. A method comprising: forming a girth hitch around ahyoid bone with a suture line, wherein a first segment of the sutureline and a second segment of the suture line pass through an arc of thesuture line; applying a tension to the suture line; passing the firstsegment and the second segment of the suture line through a passagewayof a bone anchor secured to a mandible; and securing the first segmentand the second segment to the bone anchor.
 81. The method of claim 80,further comprising forming a second girth hitch around the hyoid bonewith a second suture line.
 82. The method of claim 81, furthercomprising securing the second suture line to a second bone anchorsecured to the mandible.
 83. The method of claim 80, further comprisingpassing the suture line around the hyoid bone with a suture passerinstrument.
 84. The method of claim 83, wherein using the suture passinginstrument comprises rotating a curved suture passing element relativeto the hyoid bone.